Positive Top-Line Results for Roche MS Drug

Ocrelizumab bested interferon in two phase III clinical trials

An investigational monoclonal antibody passed critical tests in two pivotal trials, cutting relapse rates in multiple sclerosis patients, Roche announced in a release of top-line data.

A twice-yearly infusion of ocrelizumab bested interferon beta-1a (Rebif) over a period of 2 years in the OPERA I and OPERA II phase III trials, the company reported.

The drug also reduced progression of clinical disability compared with the older agent as measured by Expanded Disability Status Scale (EDSS) scores and diminished brain lesions.

The trials enrolled 1,656 patients with relapsing forms of MS -- either relapsing-remitting or secondary progressive -- at 307 sites in 40 countries.

The drug is an investigational humanized monoclonal antibody selectively targeting CD20+ B cells, which are thought to be a key contributor to myelin and axonal damage.

Roche noted that there were similar rates of common and serious adverse events. The most common adverse events were mild-to-moderate infusion-related reactions. Rates of serious infections were similar between groups, they reported.

Data from the trials will be presented at a medical meeting later this year. The company plans to submit the trial data to U.S. and European regulators in the first quarter of 2016.

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